Trials / Active Not Recruiting
Active Not RecruitingNCT05919563
LTFU Study of Subjects Who Received GRNOPC1
Long Term Follow-up of Subjects Who Received GRNOPC1
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 5 (actual)
- Sponsor
- Lineage Cell Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a LTFU study for thoracic SCI subjects that were administered GRNOPC1 cells in the main study CP35A007.
Detailed description
Study CP35A008 is a Phase 1, multi-center long term follow-up (LTFU) study for five (5) subjects with complete thoracic SCI that were administered 2 million GRNOPC1 cells in the main study CP35A007. The purpose of this study is to monitor long-term safety in subjects for 15 years post GRNOPC1 administration.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Magnetic Resonance Imaging (MRI) | Observational study; annual MRI for first 5 years only to monitor changes in the injection site |
Timeline
- Start date
- 2011-10-06
- Primary completion
- 2026-12-12
- Completion
- 2026-12-12
- First posted
- 2023-06-26
- Last updated
- 2024-08-21
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05919563. Inclusion in this directory is not an endorsement.